Patient and public involvement in randomised clinical trials: a mixed-methods study of a clinical trials unit to identify good practice, barriers and facilitators.

BACKGROUND: While patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to investigate how PPI is approached within a UK Clinical Trials Unit (CTU)'s portfolio of randomised controlled trials, perceived barriers to/facilitators of its successful implementation, and perspectives on the CTU's role in PPI. METHODS: A mixed-methods study design, involving (1) an online survey of 26 trial managers (TMs) and (2) Interviews with Trial Management Group members and public contributors from 8 case-study trials. Quantitative survey data were summarised using descriptive statistics and interview transcripts analysed thematically. Two public contributors advised throughout and are co-authors. RESULTS: (1) 21 TMs completed the survey; (2) 19 in-depth interviews were conducted with public contributors (n=8), TMs (n=5), chief investigators (n=3), PPI coordinators (n=2) and a researcher. 15/21 TMs surveyed reported that a public contributor was on the trial team, and 5 used another PPI method. 12/21 TMs reported that public contributors were paid (range £10-50/h). 5 TMs reported that training was provided for public contributors and few staff members had received any formal PPI training. The most commonly reported tasks undertaken by public contributors were the review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided. Barriers to successful PPI included recruitment challenges, group dynamics, maintaining professional boundaries, negative attitudes to PPI amongst some researchers, a lack of continuity of trial staff, and the academic environment. Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, building and maintaining relationships, and joint understanding and clarity about expectations/roles. CTUs have an important role to play in supporting recruitment, signposting and coordinating PPI. CONCLUSIONS: While highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported.

Zero-Premium Health Insurance Plans Became More Prevalent In Federal Marketplaces In 2018.

The Affordable Care Act established two federally funded subsidies-cost-sharing reductions and premium tax credits-available in the health insurance Marketplaces. In 2018 federal payments to insurers for cost-sharing reductions were terminated. Insurers responded by increasing plan premiums to account for the loss of these payments. Premiums for silver plans were increased more than those for other metal tiers because cost-sharing reductions are available only in silver plans, while premium tax credits can be applied across different metal tiers. One consequence of greater premium increases for silver plans was the increased availability and selection of plans with zero premiums for consumers. We examined the magnitude of this issue using plan selections through the federal Marketplaces during the open enrollment periods before (2017) and after (2018) the termination of payments. We found that zero-premium plan availability increased by 18.3 percentage points, selection increased by 7.9 percentage points, and selection conditional on having a zero-premium plan available increased by 8.8 percentage points. Were federal cost-sharing reduction payments to be restored, a reduction in availability and selection of zero-premium plans would likely occur, and more consumers could lose access to the plans.

Estimating the Cost of Providing Foundational Public Health Services.

OBJECTIVE: To estimate the cost of resources required to implement a set of Foundational Public Health Services (FPHS) as recommended by the Institute of Medicine. STUDY DESIGN: A stochastic simulation model was used to generate probability distributions of input and output costs across 11 FPHS domains. We used an implementation attainment scale to estimate costs of fully implementing FPHS. DATA COLLECTION/EXTRACTION METHODS: We use data collected from a diverse cohort of 19 public health agencies located in three states that implemented the FPHS cost estimation methodology in their agencies during 2014-2015. PRINCIPAL FINDINGS: The average agency incurred costs of $48 per capita implementing FPHS at their current attainment levels with a coefficient of variation (CV) of 16 percent. Achieving full FPHS implementation would require $82 per capita (CV=19 percent), indicating an estimated resource gap of $34 per capita. CONCLUSIONS: Substantial variation in costs exists across communities in resources currently devoted to implementing FPHS, with even larger variation in resources needed for full attainment. Reducing geographic inequities in FPHS may require novel financing mechanisms and delivery models that allow health agencies to have robust roles within the health system and realize a minimum package of public health services for the nation.

Time-Series Analysis of the Impact of Prescription Drug Monitoring Programs on Heroin Treatment Admissions.

BACKGROUND: Prescription drug abuse has become a major issue in the United States in recent years. Prescription drug monitoring programs (PDMPs) are designed to help health care providers to prevent such abuses. There may be unintended effects of these programs. Specifically, PDMPs may move prescription opioid users to begin use of heroin. OBJECTIVES: This article aims to evaluate the impact of PDMPs on heroin abuse across several different states through use of treatment admissions records obtained from the Treatment Episode Data Set. METHODS: Operational dates and other characteristics of state PDMPs were obtained from the Prescription Drug Monitoring Program Training and Technical Assistance Center. Data for the dependent variable were collected from the Treatment Episodes Data Set from 1992 to 2012. Interrupted time-series analyses using autoregressive integrated moving average modeling were used to estimate the effect of presence of an operational PDMP on the number of admissions reporting heroin as their primary drug being used. RESULTS: The relationship between heroin admissions and prescription opioid admissions was significant for the average data (ß = 0.41, p = 0.0017) and the 5-year data (ß = 0.5, p = 0.036), both showing positive associations between heroin and prescription drug admissions in states in the post PDMP implementation period. Conclusions/Importance: The study found a positive relationship that between heroin and prescription opioid admissions post PDMP implementation. Future research should attempt to identify what this relationship means and how this information can be used to improve opioid policy.

The biomechanical stability of salvage procedures for distal radioulnar joint arthritis.

PURPOSE: To test distal forearm stability after 3 surgical procedures for distal radioulnar joint (DRUJ) arthritis. METHODS: We tested 11 cadaver limbs with the DRUJ intact, after distal ulna-matched hemiresection, after Darrach distal ulna resection, and after unlinked total DRUJ arthroplasty. We evaluated distal forearm stability in neutral rotation, full pronation, and full supination in unweighted and 1-kg-weighted conditions. We measured dorsal/palmar translation and convergence/divergence of the distal radius relative to the ulna. RESULTS: Under neutral rotation, whether weighted or unweighted, matched hemiresection and Darrach specimens demonstrated significant radioulnar convergence relative to intact specimens. Weighted and unweighted, DRUJ arthroplasty demonstrated similar radioulnar convergence to intact. Weighted and unweighted, only Darrach specimens showed significant radius-palmar translation compared with intact, hemiresected, and DRUJ arthroplasty. In pronation, no testing scenario, either weighted or unweighted, demonstrated statistically significant radioulnar convergence relative to intact state. In unweighted pronation, palmar translation of the radius was significantly different from the intact state for all surgical scenarios and the Darrach was significantly worse than the other procedures. In weighted pronation, palmar translation of the radius was significantly different from the intact state for all surgical scenarios and the matched hemiresection was significantly better than the other procedures. In supination, weighted and unweighted, Darrach specimens had significant radioulnar convergence relative to intact. Either weighted or unweighted, the hemiresection and arthroplasty groups demonstrated similar radioulnar convergence relative to intact. Unweighted, all scenarios demonstrated similar dorsal translation of the radius. Weighted, the Darrach group showed significant radius-dorsal translation relative to intact specimens. CONCLUSIONS: For tested procedures, DRUJ arthroplasty overall was biomechanically superior to the other conditions except that we found greater stability in the hemiresected group in weighted pronation. CLINICAL RELEVANCE: Knowledge of baseline biomechanical characteristics of DRUJ arthritis procedures will aid surgical decision-making and patient counseling.

Acute mycobacterial flexor tenosynovitis following accidental bacillus calmette-guérin inoculation in a health care worker: case report.

Solutions containing bacillus Calmette-Guérin (BCG), a live attenuated form of Mycobacterium bovis or Mycobacterium tuberculosis, commonly are injected intravesically to treat tumors of the urinary bladder. We report a case of acute mycobacterial flexor tenosynovitis in a health care worker who inadvertently inoculated her finger via needlestick while preparing BCG solution for intravesicular administration. She was treated successfully with immediate operative intervention followed by 6 months of antimycobacterial antibiotics. Of 3 previous reports of hand infections following self-inoculation with BCG solutions, this case is unique owing to rapid onset of acute mycobacterial flexor tenosynovitis and positive intraoperative mycobacterial cultures. Needlesticks with BCG-containing solutions, especially into the flexor tendon sheath, should be treated with timely surgical debridement and appropriate antimycobacterial management.

Outcomes of hook of hamate fracture excision in high-level amateur athletes.

PURPOSE: To determine the overall long-term postoperative clinical and functional results of high-level amateur athletes after hook of hamate excision, based on complications; return to sport; Disabilities of the Arm, Shoulder, and Hand (DASH) score; and a self-reported questionnaire. METHODS: We evaluated 11 patients representing 12 cases of hook of hamate excision. All patients were high-level amateur athletes (rising collegiate or collegiate level). We performed a retrospective chart review to elicit information pertaining to the patient's injury. We assessed long-term postoperative outcomes with a self-reported questionnaire, the DASH form, and the DASH Sport/Performing Arts Module form. RESULTS: All patients successfully returned to full participation in their respective sports an average of 6 weeks after surgery. The average postoperative DASH score was less than 1, and all patients scored a 0 on the DASH Sports form. There was a significant improvement in preoperative pain after surgical intervention. There was no significant difference between preinjury and postoperative performance scores. Finally, every patient was very satisfied with the surgical outcome. There was only 1 postoperative complication in which a patient developed transient ulnar nerve paresthesias, which completely resolved by 6 weeks after surgery. CONCLUSIONS: Surgical excision of hook of hamate fractures in high-level amateur athletes allows for successful return to sports participation at preinjury performance levels, achievement of normal function as measured by validated objective outcome measures, significant reduction in pain, and high overall patient satisfaction. We consider surgical excision to be a safe and effective technique to restore normal function and hasten return to play for high-level amateur athletes. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Incidence and risk factors of heterotopic ossification following major elbow trauma.

Heterotopic ossification is a common complication of Orthopaedic Trauma Association (OTA) type C distal humerus fractures and ulnohumeral fracture dislocations. The purpose of this study was to precisely define the incidence of heterotopic ossification following major elbow trauma and to identify risk factors for the development of clinically significant heterotopic ossification and for surgical excision of elbow heterotopic ossification.Current Procedural Terminology codes identified 156 patients who underwent operative intervention for a distal humerus fracture or an ulnohumeral fracture dislocation at 2 Level I trauma centers over 6 years. The incidence of elbow heterotopic ossification was recorded at >90 days following the definitive procedure. Risk factors for the development of class 3 or 4 heterotopic ossification and for surgical excision of heterotopic ossification were evaluated using separate multivariable logistic regression analyses. Brooker class 3 or 4 heterotopic ossification occurred following 18 (14%) of 125 distal humerus fractures, 15 (22%) of 69 OTA type C distal humerus fractures, and 11 (35%) of 31 ulnohumeral fracture dislocations. Surgical excision of heterotopic ossification was performed after 12 (10%) of 125 distal humerus fractures, 10 (14%) of 69 OTA type C distal humerus fractures, and 8 (26%) of 31 ulnohumeral fracture dislocations. Sustaining a severe elbow injury (P<.05) or a delay of fixation (P=.05) was found to be independent risk factors for Brooker class 3 or 4 heterotopic ossification. Severe elbow injury (P<.05) and male sex (P<.05) were associated with operative excision of heterotopic ossification.

High revision and reoperation rates using the Agility™ Total Ankle System.

BACKGROUND: Total ankle arthroplasty (TAA) is an evolving treatment for end-stage ankle arthritis, however, there is controversy regarding its longevity. QUESTIONS/PURPOSES: We determined survival of the Agility™ TAA, the overall reoperation rate, and function in patients who retained their implant. METHODS: We retrospectively reviewed 64 patients who had 65 TAAs between June 1999 and May 2001. Information was gathered through chart reviews, mailed-in questionnaires, and telephone interviews. Nine patients had died; data were available for 41 of the remaining 55 patients. Survival was based on revision as an end point. The minimum followup was 0.5 years (median, 8 years; range, 0.5-11 years). RESULTS: Sixteen of the 41 patients (39%) needed revisions. The average time to revision surgery was 4 years with six of the revisions (38%) occurring within 1 year of the TAA. Of the 25 patients who retained their implants, 12 required secondary surgery for an overall reoperation rate of 28 of 41 (68%) at an average of 8 years followup. The average VAS pain score was 4, the average Foot and Ankle Ability Measure (FAAM) sports subscale score was 33, and the average FAAM activities of daily living subscale score was 57. CONCLUSION: TAA had high revision and reoperation rates. Patients who retained their implant had only moderate pain relief and function. TAA must be approached with caution. More research is needed to elucidate the role of contemporary TAA.